---
title: Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
nct_id: NCT02504164
overall_status: COMPLETED
phase: NA
sponsor: Yonsei University
study_type: INTERVENTIONAL
primary_condition: Early Gastric Cancer
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02504164.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02504164"
ct_last_update_post_date: 2016-03-07
last_seen_at: "2026-05-12T06:36:00.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection

**NCT ID:** [NCT02504164](https://clinicaltrials.gov/study/NCT02504164)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Yonsei University
- **Conditions:** Early Gastric Cancer, Gastric Adenoma
- **Start Date:** 2014-09
- **Completion Date:** 2015-12
- **CT.gov Last Update:** 2016-03-07

## Brief Summary

Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
2. American society of anesthesiologist physical status 1\~3

Exclusion Criteria:

1. Patient refusal
2. Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
3. History of gastrectomy or previous endoscopic submucosal dissection at same site
4. Allergies to propofol or its ingredients, soybeans or peanuts
5. Pregnant or breastfeeding patients
6. Patients with severe debilitating underlying medical conditions
7. Patients with altered mental status
8. Illiterate patients or foreigners
```

## Arms

- **No premedication** (EXPERIMENTAL) — No premedication before sedation
- **Midazolam** (ACTIVE_COMPARATOR) — Premedication with midazolam before sedation

## Interventions

- **midazolam 0.02mg/kg** (DRUG)
- **No premedication** (DRUG) — No premedication before sedation for endoscopic submucosal dissection

## Primary Outcomes

- **Overall patient satisfaction scores on a scale from 0 to 10** _(time frame: 24 hours after ESD)_
- **Willingness to receive same method of sedation for ESD in the future as yes or no** _(time frame: 24 hours after ESD)_
- **Post-procedural pain on a VAS scale of 0 to 10** _(time frame: at 1 hour and 24 hours after ESD)_
- **Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)** _(time frame: 24 hours after ESD)_

## Locations (1)

- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine, Seoul, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of anesthesiology and pain medicine, anesthesia and pain research institue, yonsei universiy college of medicine|seoul|seoul|south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02504164*  
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